Head of Cell Line Development

Takeda; Cambridge (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda in Cambridge, MA is seeking a Director, Head of Cell Line Development to lead a team of ~10 scientists in mammalian cell line development for a biologics portfolio including MAb and bispecifics. You will set CLD strategy, oversee MCB/WCB readiness, and drive end-to-end development from early stages through IND/IMPD with strong emphasis on data integrity and regulatory support.

The role requires a PhD or equivalent with 10+ years' experience (or MS with 12+ years, BS with 15+), proven

Qualifications

• PhD in Cell Biology, Molecular Biology, Biochemical Engineering, Biotechnology or related field with 10+ years industry experience; or MS with 12+ years; or BS with 15+ years.
• Recognized expert in Cell Line Development with track record delivering clinical production cell lines and tech transfer packages.
• Deep expertise in cell biology, host cell engineering, and expression vector design.
• Understanding impact of CLD decisions on product quality and manufacturability, incl. complex proteins and bi-specifics.
• Strong influencing, matrix leadership, collaboration, and senior stakeholder communication.
• Experience managing and coaching a scientific team; career development planning.
• Experience supporting commercial cell lines and lifecycle management with regulatory and quality awareness.

Responsibilities

• Define CLD vision, platform strategy, and roadmap aligned to portfolio demand.
• Lead a team of ~10 responsible for clinical cell line delivery and technology evaluation; drive hiring and development.
• Own budgets, cell line timelines, and CRO/CDMO governance.
• Oversee end-to-end mammalian CLD: vector/transfection strategy, cloning, screening, stability, nomination.
• Ensure fit-for-purpose characterization with upstream PD collaboration.
• Lead risk-based strategies for difficult-to-express molecules including bi-specifics.
• Maintain robust documentation of cell line history and data for filings and audits.
• Contribute to regulatory submissions and responses (IND/IMPD; later-stage support).
• Lead evaluation of new CLD technologies and external collaborations.

Skills

CLD leadership

Team coaching

Budget management

Documentation & data integrity

Regulatory submissions knowledge

Automation / HTS

Stakeholder communication

Education

PhD in Cell Biology

Master's degree

Bachelor's degree

Tools

Automation tooling

Single-cell screening tools

Analytical collaboration tools

Job description

Job Description

Job Description: Head of Cell Line Development (Director)

About the Role:

The Director, Head of Cell Line Development (CLD) provides leadership for mammalian cell line development to enable a biologics portfolio including monoclonal antibodies, bi-specifics, and adjacent molecular formats. This role sets CLD strategy, leads a team of cell and molecular biologists, and delivers high-performing production cell lines. The role enables programs from early development through IND/IMPD, with lifecycle support for commercial cell lines, as needed. This role is accountable for oversight of GMP cell banking activities (MCB/WCB readiness and governance).

How you will contribute:

• Define CLD vision, platform strategy, and roadmap aligned to portfolio demand (including complex/next-gen antibody formats).
• Lead, coach, and develop a team of ~10 responsible for clinical cell line delivery and technology evaluation; drive hiring, capability development, and succession planning.
• Own functional budget, cell line timelines, and vendor governance for CRO/CDMO support where used.

• Provide technical and operational oversight of end-to-end mammalian cell line development: vector/transfection strategy, selection systems, single-cell cloning, clone screening, stability assessment, and candidate cell line nomination.
• Ensure fit-for-purpose characterization packages (growth, productivity, stability, and product quality) in collaboration with upstream process development.
• Lead risk-based strategies for difficult-to-express and complex molecules (e.g., bi-specifics), including mitigation plans and decision criteria.
• Ensure robust documentation of cell line history, clonality rationale, traceability, and data integrity to support filings and audits. Contribute to regulatory submissions and responses (e.g., IND/IMPD; later-stage support as needed).

• Accountable for cell banking strategy and execution, including readiness for MCB/WCB generation. Ensure clear, compliant handoffs and documentation for cell bank production (internal or external), including batch records/data packages and deviations/investigations support as applicable.

• Lead evaluation, selection, and implementation of new CLD technologies (host cell/selection systems, single-cell tools, automation, analytics, digital/AI-enabled screening, etc.). Work closely with upstream process development to ensure platform fit of changes/optimization to the host cell line/vectors and/or workflow.
• Build external collaborations with technology providers and academic/industry partners to maintain competitive CLD capabilities.

Skills and qualifications:

* PhD in Cell Biology, Molecular Biology, Biochemical Engineering, Biotechnology, or a related scientific discipline with 10+ years of relevant industry experience; or Master's degree with 12+ years; or Bachelor's degree with 15+ years
* Recognized expert in Cell Line Development, with a demonstrated track record of delivering clinical production cell lines with strong documentation and tech transfer packages.

* Possesses deep expertise in cell biology, host cell engineering, and expression vector design. Recognized as a subject matter expert with broad awareness of emerging technologies and trends across the industry.

* Strong understanding of how CLD decisions impact product quality and manufacturability, particularly for bi-specifics and complex proteins.
* Recognized as an expert in influencing, able to manage in a matrix environment, collaborate across functions, and communicate effectively to senior stakeholders.
* Extensive experience in managing and coaching a team of scientists at all levels and establishing strong career development plans.

* Experience supporting commercial cell lines and lifecycle management (e.g., investigations, comparability/change control inputs) with an understanding of the regulatory and quality requirements for establishment of MCB/WCBs and IND/BLA submissions.

* Demonstrated success implementing automation/high-throughput screening and collaborating with analytical colleagues to improve cycle times.

* Recognized expert in troubleshooting, able to solve strategic problems, and coaching others.
As a recognized expert within Takeda globally, you possess in-depth expertise in your discipline and knowledge across related areas. You're adept at anticipating internal/external challenges, recommending improvements, and solving unique technical and strategic problems. Your role involves working on complex issues, contributing to BPD strategy, and serving as the primary contact for cell line related contracts and operations and conducting briefings and meetings with management.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

USA - MA - Cambridge - Binney St

U.S. Base Salary Range:

$177,000.00 - $278,080.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

USA - MA - Cambridge - Binney St

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.